PEMETREXED GLENMARK 500 mg POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Pemetrexed Glenmark100 mg powder for concentrate for solution for infusion EFG

Pemetrexed Glenmark500 mg powder for concentrate for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pemetrexed Glenmark and what is it used for
2. What you need to know before you use Pemetrexed Glenmark
3. How to use Pemetrexed Glenmark
4. Possible side effects
5. Storage of Pemetrexed Glenmark
6. Contents of the pack and other information

1. What is Pemetrexed Glenmark and what is it used for

Pemetrexed is a medicine used to treat cancer.

This medicine can be given with cisplatin, another anticancer medicine, as a treatment for malignant pleural mesothelioma, a type of cancer that affects the lining of the lungs, in patients who have not received chemotherapy before.

Pemetrexed can also be given in combination with cisplatin for the initial treatment of patients with advanced stages of lung cancer.

Pemetrexed may be prescribed for you if you have advanced lung cancer if your disease has responded to treatment or if it remains unchanged after initial chemotherapy.

Pemetrexed can also be given for the treatment of patients with advanced stages of lung cancer whose disease has progressed, who have already received other initial chemotherapy treatment.

2. What you need to know before you use Pemetrexed Glenmark

Do not use Pemetrexed Glenmark

• if you are allergic (hypersensitive) to pemetrexed or to any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding, you must stop breastfeeding during treatment with pemetrexed.
• if you have recently been given or are going to be given the yellow fever vaccine.

Warnings and precautions

Consult your doctor or hospital pharmacist before starting to use this medicine.

If you have or have had kidney problems, consult your doctor or hospital pharmacist as you may not be able to receive pemetrexed.

Before each infusion, you will need to give blood samples to check if your kidney and liver function is sufficient and to check if you have enough blood cells to receive pemetrexed. Your doctor may decide to change your dose or delay treatment depending on your general condition and if your blood cell count is too low. If you are also receiving cisplatin, your doctor will make sure you are properly hydrated and receive appropriate treatment before and after receiving cisplatin to prevent vomiting.

If you have received or are going to receive radiotherapy, please consult your doctor, as a reaction to radiation with pemetrexed may occur.

If you have been vaccinated recently, please consult your doctor, as this may cause some negative effect with pemetrexed.

If you have heart disease or a history of heart disease, please consult your doctor.

If you have fluid accumulation around the lung, your doctor may decide to remove the fluid before administering pemetrexed.

Children and adolescents

This medicine must not be used in children or adolescents, as there is no experience with this medicine in children and adolescents under 18 years.

Other medicines and Pemetrexed Glenmark

Consult your doctor if you are taking any medicine for pain or inflammation (swelling), such as medicines called "non-steroidal anti-inflammatory medicines" (NSAIDs), including those bought without a prescription (such as ibuprofen). There are many classes of NSAIDs with different durations of action. Depending on the scheduled date for your pemetrexed infusion and/or the status of your kidney function, your doctor should advise you on which medicines you can use and when you can take them. If you are unsure, consult your doctor or pharmacist in case any medicine you are taking is an NSAID.

Inform your doctor if you are taking medicines called proton pump inhibitors (omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole) used to treat stomach acid and acid reflux.

Inform your doctor or hospital pharmacist if you are taking, have recently taken, or might take any other medicine, including those bought without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

The use of pemetrexed should be avoided during pregnancy. Your doctor will inform you of the possible risks of using pemetrexed during pregnancy. Women must use effective contraceptive methods during treatment and up to 6 months after the last dose of pemetrexed.

Breastfeeding

If you are breastfeeding, inform your doctor.

Breastfeeding must be stopped during treatment with pemetrexed.

Fertility

Male patients are advised not to father a child during and up to 3 months after treatment with pemetrexed and must use effective contraceptive methods during and up to 3 months after treatment with pemetrexed. If you wish to have a child during treatment or in the 3 months following treatment, ask your doctor or pharmacist for advice. Due to the possibility that treatment with pemetrexed may cause infertility, male patients are advised to seek advice on the possibility of going to a sperm bank before starting treatment.

Driving and using machines

Pemetrexed may cause fatigue. Be careful when driving a car or using machines.

Pemetrexed Glenmark contains sodium

Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion:

This medicine contains less than 1 mmol of sodium (23 mg) per vial; this is essentially "sodium-free".

Pemetrexed Glenmark 500 mg powder for concentrate for solution for infusion:

This medicine contains 54 mg of sodium (main component of cooking/table salt) in each vial. This is equivalent to 2.7% of the maximum recommended daily intake of sodium for an adult.

3. How to use Pemetrexed Glenmark

The recommended dose of pemetrexed is 500 milligrams per square meter of your body surface area. Your height and weight will be measured to calculate your body surface area. Your doctor will use this body surface area to calculate the correct dose for you. This dose may be adjusted, or treatment may be delayed depending on your blood cell count and your general condition. The hospital pharmacist, nurse, or doctor will have mixed the pemetrexed powder with a solution of sodium chloride for injection 9 mg/ml (0.9%) before it is given to you.

You will always receive pemetrexed through an infusion in one of your veins. The infusion will last about 10 minutes.

When using pemetrexed in combination with cisplatin:

The doctor or hospital pharmacist will calculate the dose based on your height and weight. Cisplatin is also given through an infusion in one of your veins and is given about 30 minutes after the pemetrexed infusion has finished. The cisplatin infusion will last about two hours.

Normally, you should receive your infusion once every three weeks.

Additional medication:

Corticosteroids: your doctor will prescribe steroid tablets (equivalent to 4 milligrams of dexamethasone twice a day) that you must take the day before, the day of, and the day after treatment with pemetrexed. This medicine is given to reduce the frequency and severity of skin reactions you may experience during your anticancer treatment.

Vitamin supplement: your doctor will prescribe oral folic acid (vitamin) or a multivitamin complex containing folic acid (350 to 1,000 micrograms) that you must take once a day while you are using pemetrexed. You must take at least five doses during the seven days before the first dose of pemetrexed. You must continue taking folic acid during 21 days after the last dose of pemetrexed. Additionally, you will receive a vitamin B12 injection (1,000 micrograms) in the week before pemetrexed administration and then approximately every 9 weeks (corresponding to 3 cycles of treatment with pemetrexed). Vitamin B12 and folic acid are given to reduce the possible toxic effects of anticancer treatment.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You must inform your doctor immediately if you notice any of the following symptoms:

• Fever or infection (frequent or very frequent, respectively): if you have a temperature of 38°C or higher, sweating, or other signs of infection (as you may have fewer white blood cells than normal, which is very frequent). Infections (sepsis) can be serious and life-threatening.
• If you start to feel chest pain (frequent) or your heart rate is faster (uncommon).
• If you have pain, redness, swelling, or sores in the mouth (very frequent).
• Allergic reaction: if you develop a rash (very frequent) / burning sensation or itching (frequent), or fever (frequent). In rare cases, skin reactions can be serious and life-threatening. Contact your doctor if you experience severe rash, or itching, or blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis).
• If you experience fatigue, dizziness, shortness of breath, or if you are pale (as you may have fewer red blood cells than normal, which is very frequent).
• If you experience bleeding from the gums, nose, or mouth, or any bleeding that does not stop, red or pink urine, unexpected bruising (as you may have fewer platelets than normal, which is frequent).
• If you experience sudden difficulty breathing, severe chest pain, or coughing up blood in your sputum (uncommon) (may indicate that there is a blood clot in the veins of the lungs).

Side effects with pemetrexed may include:

Very common(may affect more than 1 in 10 people):

• Infection
• Pharyngitis (sore throat)
• Low number of neutrophil granulocytes (a type of white blood cell)
• Low white blood cell count
• Low hemoglobin levels
• Pain, redness, swelling, or sores in the mouth
• Lack of appetite
• Vomiting
• Diarrhea
• Nausea
• Rash
• Peeling skin
• Abnormal blood tests showing reduced kidney function
• Fatigue (tiredness)

Common(may affect up to 1 in 10 people):

• Blood infection
• Fever with low number of neutrophil granulocytes (a type of white blood cell)
• Low platelet count
• Allergic reaction
• Loss of body fluids
• Altered sense of taste
• Nerve damage that can cause muscle weakness and wasting (mainly in arms and legs)
• Nerve damage that can cause loss of sensation, burning pain, and unsteady gait
• Dizziness
• Inflammation or swelling of the conjunctiva (membrane covering the eyelids and the white part of the eye)
• Dry eyes
• Tearing eyes
• Dryness of the conjunctiva (membrane covering the eyelids and the white part of the eye) and the cornea (transparent layer in front of the iris and pupil)
• Swelling of the eyelids
• Ocular disorder with dryness, tearing, irritation, and/or pain
• Heart failure (a condition that affects the heart's pumping ability)
• Irregular heartbeat
• Indigestion
• Constipation
• Abdominal pain
• Liver: increased levels of chemicals in the blood produced by the liver
• Increased skin pigmentation
• Itching skin
• Rash on the body where each lesion looks like a target
• Hair loss
• Hives
• Kidney failure
• Fever
• Reduced kidney function
• Pain
• Excess fluid in the body tissue, causing swelling
• Chest pain
• Inflammation and ulceration of the mucous membranes lining the digestive tract

Uncommon(may affect up to 1 in 100 people):

• Decrease in the number of red blood cells, white blood cells, and platelets
• Ischemia
• Ischemia due to blockage of a cerebral artery
• Intracranial bleeding
• Angina (chest pain caused by reduced blood flow to the heart)
• Heart attack
• Narrowing or blockage of the coronary arteries
• Increased heart rate
• Poor distribution of blood to the limbs
• Blockage in one of the pulmonary arteries in the lungs
• Inflammation and scarring of the lining of the lungs with breathing problems
• Bright red blood loss through the anus
• Bleeding in the gastrointestinal tract
• Perforation of the intestine
• Inflammation of the lining of the esophagus
• Inflammation of the lining of the large intestine, which may be accompanied by intestinal or rectal bleeding (seen only in combination with cisplatin)
• Inflammation, edema, erythema, and erosion of the mucous membrane surface of the esophagus caused by radiotherapy
• Radiation-induced lung inflammation

Rare(may affect up to 1 in 1,000 people):

• Destruction of red blood cells
• Anaphylactic shock (severe allergic reaction)
• Inflammatory liver disease
• Redness of the skin
• Rash on the skin that develops in a previously irradiated area

Very rare(may affect up to 1 in 10,000 people):

• Infections of the skin and soft tissues
• Stevens-Johnson syndrome (a type of severe skin and mucous membrane reaction that can be life-threatening)
• Toxic epidermal necrolysis (a type of severe skin reaction that can be fatal)
• Autoimmune disorder that causes skin rashes and blisters on the legs, arms, and abdomen
• Inflammation of the skin characterized by the presence of blisters that are filled with fluid
• Skin fragility, blisters, and erosions and scarring of the skin
• Redness, pain, and swelling mainly of the lower limbs
• Inflammation of the skin and the fat under the skin (pseudocellulitis)
• Inflammation of the skin (dermatitis)
• The skin becomes inflamed, itchy, red, cracked, and rough
• Itchy patches

Frequency not known(frequency cannot be estimated from the available data):

• A type of diabetes derived mainly from kidney disease
• Kidney disorder involving the death of the epithelial tubular cells that form the renal tubules

You may experience some of these symptoms and/or situations. You must inform your doctor as soon as you start experiencing any of these side effects.

If you are concerned about any side effect, consult your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pemetrexed Glenmark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Reconstituted and infusion solution: this medicine must be used immediately. When prepared as indicated, the chemical and physical stability in use of the reconstituted and infusion solution is 48 hours in refrigeration.

This medicine is for single use; the unused solution must be discarded in accordance with local regulations.

6. Container Content and Additional Information

Pemetrexed Glenmark Composition

The active ingredient is pemetrexed.

• Pemetrexed Glenmark 100 mg: each vial contains pemetrexed disodium heptahydrate equivalent to 100 mg of pemetrexed.
• Pemetrexed Glenmark 500 mg: each vial contains pemetrexed disodium heptahydrate equivalent to 500 mg of pemetrexed.

After reconstitution, the solution contains 25 mg/ml of pemetrexed. Before administration, it is required that the healthcare professional perform another dilution.

The other components are mannitol (E 421), hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

Product Appearance and Container Content

Pemetrexed Glenmark is a powder for concentrate for solution for infusion in a vial. It is a white to pale yellow or yellowish-green cake or lyophilized powder.

It is available in packs of 1 vial.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Apis labor GmbH

Resslstraße 9

Ebenthal, 9065

Austria

Further information about this medicinal product can be obtained from the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Pemetrexed Glenmark 100 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Pemetrexed Glenmark 500 mg Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

Spain: Pemetrexed Glenmark 100 mg powder for concentrate for solution for infusion EFG

Pemetrexed Glenmark 500 mg powder for concentrate for solution for infusion EFG

Sweden: Pemetrexed Glenmark 100 mg pulver till koncentrat till infusionsvätska, lösning

Pemetrexed Glenmark 500 mg pulver till koncentrat till infusionsvätska, lösning

Norway: Pemetrexed Glenmark 100 mg pulver til konsentrat til infusjonsvæske, oppløsning

Pemetrexed Glenmark 500 mg pulver til konsentrat til infusjonsvæske, oppløsning

Denmark: Pemetrexed Glenmark

Finland: Pemetrexed Glenmark 100 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos

Pemetrexed Glenmark 500 mg kuiva-aine välikonsentraatiksi infuusionestettä varten, liuos

Poland: Pemetrexed Glenmark

Italy: Pemetrexed Glenmark 100 mg polvere per concentrato per soluzione per infusione

Pemetrexed Glenmark 500 mg polvere per concentrato per soluzione per infusione

Date of the last revision of this leaflet:April 2025.

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).